• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Nutraceuticals
    • Markets
    • Health
    • Jobs
    • Events
    • Buyers' Guide
    • Showcases
    • More
  • Magazine
  • News
  • Exclusives
  • Nutraceuticals
  • Markets
  • Health
  • Jobs
  • Events
  • Buyers' Guide
  • Showcases
  • Current & Past Issues
    Features
    Columns
    Editorials
    Digital Edition
    Subscribe Now
    Advertise Now
    eNewsletter
    Editorial Guidelines
    Top Features
    Health Products Association - China Executive Director Reflects on Market Dynamics, Challenges

    Blood Sugar Management: Personalized Testing Drives Home The Need for Early Intervention

    New and Evolving Formulation Options Must Be Mindful of Blood Sugar Maintenance

    Tapping Functional Beverages to Meet Modern Wellness Needs

    Adaptogens: Where Ancient Remedies Meet Modern Wellness Products
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Japanese Mushroom Extract Appears Helpful in HPV Infections

    Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected

    United Plant Savers Launches First Film Festival

    Azelis Opens Food and Nutrition Lab in Cairo, Egypt

    Florida Food Products Acquires Javo
    Exclusives
    Blogs & Guest Articles
    Health E-Insights
    Area Code 420
    eBook
    Antioxidants
    Dairy-Based Ingredients
    Enzymes
    Fatty Acids
    Fiber & Carbohydrates
    Green Foods
    Herbs & Botanicals
    Marine Nutraceuticals
    Minerals
    Omega 3s
    Probiotics & Prebiotics
    Proteins, Peptides, Amino Acids
    Sweeteners
    Vitamins

    Japanese Mushroom Extract Appears Helpful in HPV Infections

    United Plant Savers Launches First Film Festival

    Roquette Launches Nutralys Rice Protein

    Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development

    Study Reveals Low Intake of Tocotrienols in Polish Population
    Consumer Trends
    Contract Manufacturing
    Cosmeceuticals / Nutricosmetics
    Delivery & Dosage Technologies
    Dietary Supplements
    Flavors & Colors
    Functional Foods & Beverages
    Healthcare Trends
    Medical Nutrition
    Mergers & Acquisitions
    Natural/Organic
    Nutrition Bars
    Packaging
    Pet Nutraceuticals
    Quality & Safety
    Regulations
    Research
    Testing
    World Markets

    Japanese Mushroom Extract Appears Helpful in HPV Infections

    Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected

    Azelis Opens Food and Nutrition Lab in Cairo, Egypt

    Florida Food Products Acquires Javo

    Roquette Launches Nutralys Rice Protein
    Bone & Joint Health
    Cancer Risk
    Cardiovascular Health
    Cognitive Function
    Diabetes & Blood Sugar Management
    Digestive Health
    Energy
    Eye Health
    Healthy Aging
    Immune Function
    Infant & Children's Health
    Inflammation
    Men's Health
    Mood Health & Sleep
    Oral Health
    Sexual & Reproductive Health
    Skin Health
    Sports Nutrition
    Weight Management/Weight Loss
    Women's Health

    Japanese Mushroom Extract Appears Helpful in HPV Infections

    Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development

    Botanical Gum for Kids Aims to Curb Sugar Cravings

    Combination of Collagen and Boswellia Serrata Shown to Reduce Joint Discomfort

    Childhood Fitness and Obesity Impact Cognition Later in Life, Study Finds
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Gencor

    Aiya America, Inc. (Aiya Matcha)

    KLK OLEO

    Atlantia Clinical Trials

    Bioactive Resources
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    Gencor

    Aiya America, Inc. (Aiya Matcha)

    KLK OLEO

    Atlantia Clinical Trials

    Bioactive Resources
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Buyers' Guide
      • All Companies
      • Categories
      • Trade Associations
      • Company Capabilities
    • Nutraceuticals
      • Antioxidants
      • Dairy-Based Ingredients
      • Enzymes
      • Fatty Acids
      • Fiber & Carbohydrates
      • Green Foods
      • Herbs & Botanicals
      • Marine Nutraceuticals
      • Minerals
      • Omega 3s
      • Probiotics & Prebiotics
      • Proteins, Peptides, Amino Acids
      • Sweeteners
      • Vitamins
    • Markets
      • Consumer Trends
      • Contract Manufacturing
      • Cosmeceuticals / Nutricosmetics
      • Delivery & Dosage Technologies
      • Dietary Supplements
      • Flavors & Colors
      • Functional Foods & Beverages
      • Healthcare Trends
      • Medical Nutrition
      • Mergers & Acquisitions
      • Natural/Organic
      • Nutrition Bars
      • Packaging
      • Pet Nutraceuticals
      • Quality & Safety
      • Regulations
      • Research
      • Testing
      • World Markets
    • Health
      • Bone & Joint Health
      • Cancer Risk
      • Cardiovascular Health
      • Cognitive Function
      • Diabetes & Blood Sugar Management
      • Digestive Health
      • Energy
      • Eye Health
      • Healthy Aging
      • Immune Function
      • Infant & Children's Health
      • Inflammation
      • Men's Health
      • Mood Health & Sleep
      • Oral Health
      • Sexual & Reproductive Health
      • Skin Health
      • Sports Nutrition
      • Weight Management/Weight Loss
      • Women's Health
    • Online Exclusives
    • Webinars
    • Slideshows
    • Blogs & Guest Articles
    • Health E-Insights
    • Videos
    • Podcasts
    • Infographics
    • eBook
    • Whitepapers
    • Research
      • TrendSense
      • Monograph Center
      • White Papers
      • Research News
    • Jobs
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Supplier Showcases
      • Companies
      • Product Releases
      • News Releases
      • Literature / Brochures
      • White Papers
      • Jobs
      • VIdeos
      • Services
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA Cracks Down on Products Claiming to Treat Alzheimer’s Disease

    Failure to correct violations may result in legal action, including product seizure and/or injunction.

    FDA Cracks Down on Products Claiming to Treat Alzheimer’s Disease
    Related CONTENT
    • FDA Plans to Modernize Dietary Supplement Regulations
    • AHPA Revises Hemp-CBD Status Report
    • Brain Health Supplement Aims to Improve Cognition, Memory
    • Study: NR During Breastfeeding Yields Lasting Benefits to Mothers and Offspring in Animal Model
    • 2018 Farm Bill Brings Victory for Hemp, Uncertainty for CBD
    02.12.19
    The U.S. Food and Drug Administration has issued 12 warning letters and five online advisory letters to foreign and domestic companies illegally selling more than 58 products—many that are sold as dietary supplements—which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions.
     
    These products, which are often sold on websites and social media platforms, have not been reviewed by FDA and are not proven safe and effective to treat the diseases and health conditions they claim to treat. These products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment, the agency stated.
     
    “Science and evidence are the cornerstone of the FDA’s review process and are imperative to demonstrating medical benefit, especially when a product is marketed to treat serious and complex diseases like Alzheimer’s,” said FDA Commissioner Scott Gottlieb, MD. “Alzheimer’s is a challenging disease that, unfortunately, has no cure. Any products making unproven drug claims could mislead consumers to believe that such therapies exist and keep them from accessing therapies that are known to help support the symptoms of the disease, or worse as some fraudulent treatments can cause serious or even fatal injuries. Simply put, health fraud scams prey on vulnerable populations, waste money, and often delay proper medical care—and we will continue to take action to protect patients and caregivers from misleading, unproven products.”
     
    The agency’s actions are part of the FDA’s larger effort to address growth of the dietary supplement industry through the implementation of modern regulatory initiatives designed to preserve the balanced vision of the Dietary Supplement Health and Education Act (DSHEA), enacted by Congress 25 years ago.
     
    “That law sought to achieve the right balance between preserving consumers’ access to lawful supplements, promoting innovation in these products, while upholding our obligation to protect the public from unsafe and unlawful products and holding accountable those actors who are unable or unwilling to comply with the requirements of the law,” said Gottlieb. “Our newest policy efforts will seize the game-changing opportunity to further strengthen the regulatory framework overseeing dietary supplements and will hone in on important steps to both promote industry innovation while upholding the safety of these products as part of our overall commitment to protecting public health.”
     
    The products cited in the warning and online advisory letters include a variety of product types, such as tablets, capsules, and oils. The companies have been asked to respond to the FDA within 15 days of receipt of the letters, stating how the violations outlined in the agency’s letters will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.
     
    The FDA has issued more than 40 warning letters in the past five years to companies illegally marketing over 80 products making Alzheimer’s disease claims on websites, social media, and in stores. “We’ve also taken action in recent years against companies and dietary supplements making similar claims for the treatment of serious conditions such as cancer and opioid addiction,” Gottlieb noted. “Although these companies may have stopped selling the products or making unproven claims, numerous unsafe and unapproved products continue to be sold directly to consumers due in part to the ease with which companies can move their marketing operations to new websites.”
     
    The FDA continues to encourage consumers to remain vigilant whether online or in a store in order to avoid purchasing products that claim to prevent, treat or cure diseases without any proof they will work. Healthcare professionals and consumers are also advised to report adverse reactions associated with these or similar products to the agency’s MedWatch program.
    Related Searches
    • Regulations
    • Health
    • Dietary Supplement
    • Regulatory
    Related Knowledge Center
    • Dietary Supplements
    • Quality & Safety
    • Regulations
    Suggested For You
    FDA Plans to Modernize Dietary Supplement Regulations FDA Plans to Modernize Dietary Supplement Regulations
    AHPA Revises Hemp-CBD Status Report AHPA Revises Hemp-CBD Status Report
    Brain Health Supplement Aims to Improve Cognition, Memory Brain Health Supplement Aims to Improve Cognition, Memory
    Study: NR During Breastfeeding Yields Lasting Benefits to Mothers and Offspring in Animal Model Study: NR During Breastfeeding Yields Lasting Benefits to Mothers and Offspring in Animal Model
    2018 Farm Bill Brings Victory for Hemp, Uncertainty for CBD 2018 Farm Bill Brings Victory for Hemp, Uncertainty for CBD
    Fiber Revisited: Closing the Gap Fiber Revisited: Closing the Gap
    Nutritional Supplements Access Preserved in Arizona Nutritional Supplements Access Preserved in Arizona
    FDA Launches Dietary Supplement Working Group FDA Launches Dietary Supplement Working Group
    Examining Testing & Certification for Dietary Supplements Examining Testing & Certification for Dietary Supplements
    Green Foods: Whole Nutrition for Health-Minded Consumers Green Foods: Whole Nutrition for Health-Minded Consumers
    MarketWatch 2018 MarketWatch 2018
    Parabel Earns GRAS No Objection Letter For LENTEIN Parabel Earns GRAS No Objection Letter For LENTEIN

    Related Online Exclusives

    • Dietary Supplements | Quality & Safety | Regulations
      FDA Plans to Modernize Dietary Supplement Regulations

      FDA Plans to Modernize Dietary Supplement Regulations

      Agency seeks to balance consumer access to safe, lawful products while promoting industry innovation.
      By Sean Moloughney, Editor 02.12.19

    • Breaking News | Herbs & Botanicals | Industry & Market News | Regulations | Regulatory News
      AHPA Revises Hemp-CBD Status Report

      AHPA Revises Hemp-CBD Status Report

      The new draft addresses the recent FDA statement on hemp, CBD, and the 2018 Farm Bill; as well as state and tribal authority.
      02.01.19

    • Breaking News | Cognitive Function | Dietary Supplements | Healthy Aging | Herbs & Botanicals | Products
      Brain Health Supplement Aims to Improve Cognition, Memory

      Brain Health Supplement Aims to Improve Cognition, Memory

      Product developed by former Mayo Clinic neuroscientist.
      01.25.19


    • Breaking News | Infant & Children's Health | Research | Research News | Vitamins | Women's Health

      Study: NR During Breastfeeding Yields Lasting Benefits to Mothers and Offspring in Animal Model

      Preclinical lactation study of a unique form of vitamin B3 (nicotinamide riboside) shows measurable results in rodents.
      01.23.19

    • Dietary Supplements | Herbs & Botanicals | Quality & Safety | Regulations
      2018 Farm Bill Brings Victory for Hemp, Uncertainty for CBD

      2018 Farm Bill Brings Victory for Hemp, Uncertainty for CBD

      While hemp and its derivatives can now be legal dietary ingredients, the status of CBD is still in doubt.
      By Lisa Olivo, Associate Editor 01.14.19

    Loading, Please Wait..
    Trending
    • Three Grams Of Omega-3s May Be Optimal Dose For Reducing Blood Pressure
    • 3 grams of Omega-3s May be Optimal Dose for Reducing Blood Pressu
    • Olive/Pomegranate Extract May Improve Dyslipidemia
    Breaking News
    • Japanese Mushroom Extract Appears Helpful in HPV Infections
    • Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected
    • United Plant Savers Launches First Film Festival
    • Azelis Opens Food and Nutrition Lab in Cairo, Egypt
    • Florida Food Products Acquires Javo
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • Tapping Functional Beverages to Meet Modern Wellness Needs
    • Adaptogens: Where Ancient Remedies Meet Modern Wellness Products
    • New and Evolving Formulation Options Must Be Mindful of Blood Sugar Maintenance
    • Health Products Association - China Executive Director Reflects on Market Dynamics, Challenges
    • Blood Sugar Management: Personalized Testing Drives Home The Need for Early Intervention
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Japanese Mushroom Extract Appears Helpful in HPV Infections
    Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected
    United Plant Savers Launches First Film Festival
    Coatings World

    Latest Breaking News From Coatings World

    American Colors to Expand Sandusky, Ohio Facility
    Vaughn O’Dea Named Director of Epoxytec
    Dr. Tammo Boinowitz to Join ALTANA's Management Board
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Accelmed Partners II, Lauxera Capital Partners Invest in Veranex
    Agnes Lee Named SVP of Investor Relations, Strategic Planning at Inogen
    Dr. Brandee Pappalardo Joins Fresenius Kabi as Chief Medical Officer
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Ixaka & Minaris Sign Tech Transfer & GMP Manufacturing Agreement for Cell Therapy Candidate
    Pfizer, BioNTech Adapt COVID Vax Against Omicron
    CoreRx Expands Capabilities
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Top 5 Beauty Tech Trends at Perfect Corp.'s Global Forum
    John Frieda Supports the LGBTQIA+ Community
    Athena Club Launches in Canada
    Happi

    Latest Breaking News From Happi

    Color Street Celebrates Foster, Adoption Awareness with Limited-Edition Print
    CIR Panel Conducts 161st Meeting Regarding Safety Assessments for Cosmetic Ingredients
    DIY Nail Care Is Outperforming the Professional Segment: Kline
    Ink World

    Latest Breaking News From Ink World

    Dr. Tammo Boinowitz to Join Management Board of ALTANA AG
    Flint Offset Packaging Solutions Announces Price Increases for Sheetfed Inks
    Weekly Recap: INX’s VC Fund, Screen Industry and Ball Top This Week’s News
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Harveer Sahni recognized with Global Achievement Award
    Color-Logic partners with Taktiful 
    ALTANA announces Management Board change
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Fibertex Personal Care Awarded EcoVadis Awards for Sustainability
    Yanpai Orders Batt Forming Equipment for Needlepunch Line
    Weekly Recap: SWM and Neenah Introduce Mativ Inc., Avgol honored for Biotransformation Technology & More
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Researchers Discover Novel Patching Material for Bone Defects
    Boston Centerless Opens Second Manufacturing Plant in Indiana
    Researchers Develop Patient-Specific 3D-Printed Smart Metamaterial Implants
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Identiv-Powered CVS Spoken Rx Wins NFC Forum 2022 Innovation Award
    LG Display Announces Winners of This Year’s OLEDs GO! Competition
    Weekly Recap: eMagin, Applied Materials, and Schott Top This Week’s Stories

    Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login